Cleared Traditional

K093928 - SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

K093928 is an FDA 510(k) clearance for SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K093928 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
97d
Days
Class 2
Risk

K093928 is an FDA 510(k) clearance for the SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 29, 2010 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K093928

510(k) Number K093928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date March 29, 2010
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K093928.
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · Synthes (Usa) · Apr 2010
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
K092493 · Gpc Medical, Ltd. · Mar 2010
SYNTHES STERNAL FIXATION SYSTEM
K093772 · Synthes · Mar 2010
SMPLE PLATE AND SCREWS
K093983 · Biomet Trauma (Aka Ebi, Lp) · Mar 2010
TC PLATING SYSTEM
K094037 · Ortho-Pro, LLC · Mar 2010
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
K093761 · Biomet Trauma (Aka Ebi, Lp) · Mar 2010
K093928 · SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
Download PDF FDA Summary Synthes (Usa)